Clinical trial · Interventional
A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
A Randomized Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
NCT04987359CI-TRIAL-00091779Small StepscompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Lifestyle Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multimodal Lifestyle Program
- description
- The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. The main objective of the structured exercise training is to improve cardiorespiratory fitness.
- interventionNames
- Behavioral: Multimodal Lifestyle Program
- type
- NO_INTERVENTION
- label
- Waitlist Control
- description
- The waitlist control group will be asked to maintain their current exercise and dietary habits for the 10-week study period. Upon providing study endpoint data at week 10, control group participants will be offered a 4-week multimodal lifestyle program that is similar to the intervention group.
Primary outcomes (2)
- measure
- Change in cardiorespiratory fitness capacity (co-primary)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to provide informed consent before any trial-related activities * History of any malignancy * Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate) * No evidence of residual or recurrent cancer under active treatment * Age ≥18 years * Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions * Willing to be randomized * Allow the collection and storage of biospecimens and data for future use Exclusion Criteria: * Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks * Significant purposeful weight loss (\>11 kg) within the past 12 weeks * Current use of medications or devices for the purpose of weight loss * Metabolic or bariatric surgery within the last year * Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program * Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks * Psychiatric disorders or conditions that would preclude participation in the study intervention * Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study
References
Publications (1)
- DERIVEDBrown JC, Nauta P, Whitehead D, Dubin BR, Nash R, Blumberg K, Green T, Brown J, Compton SLE, Miletello GP. A randomized trial of a multimodal lifestyle intervention in cancer survivors. Front Oncol. 2025 Oct 2;15:1682244. doi: 10.3389/fonc.2025.1682244. eCollection 2025. PMID 41114371